01 1Quimica Sintetica
01 1KETOROLAC TROMETHAMINE
01 1Spain
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2017-07-20
Pay. Date : 2017-01-23
DMF Number : 11980
Submission : 1996-05-24
Status : Active
Type : II
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Quimica Sintetica Sa, based in Spain, is a pharmaceutical company that stands out with its certifications from EDQM.
One of their notable products is KETOROLAC TROMETHAMINE, with a corresponding US DMF Number 11980.
Remarkably, this DMF maintains an Active status since its submission on May 24, 1996, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of July 20, 2017, and payment made on January 23, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II
